← Back to Search

Radiation

Stereotactic Ablative Radiotherapy for Prostate Cancer

Phase 1
Waitlist Available
Led By Raquibul Hannan, MD
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All patients must be willing and capable to provide informed consent to participate in the protocol
Histologic confirmation of diagnosis of adenocarcinoma of the prostate will be required by biopsy
Must not have
Patients diagnosed with severe, active co-morbidity, defined as follows are not eligible: Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months, Transmural myocardial infarction within the last 6 months, Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration, Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration, Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects, Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition
Eligible patients should not have had previous pelvic radiotherapy, chemotherapy or surgery for prostate cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is being done to find the maximum amount of radiation that can be given to the prostate and pelvic areas without causing too much toxicity. They will also be using cone-beam computed tomography (CT) and high-speed graphics processing unit (GPU) to help plan and give the radiation treatment. Another goal is to find out if temporal enhanced ultrasound can help track the prostate lesion during radiation therapy.

Who is the study for?
Men over 18 with high-risk prostate cancer (Gleason score ≥8, PSA ≥20 ng/ml, or advanced stage) who can undergo MRI and are eligible for a rectal spacer. They must agree to use contraception during treatment and be able to give informed consent. Excluded are those with prior pelvic cancer treatments, certain heart conditions, active infections, recent TURP surgery, planned antineoplastic therapies, metastases evidence after staging studies, severe co-morbidities like AIDS or significant psychiatric illness.
What is being tested?
The trial tests the highest safe radiation dose that can be given to the prostate and pelvis using Stereotactic Ablative Radiotherapy (SABR). It also assesses real-time planning safety with cone-beam CT scans and GPU systems for each treatment fraction. The study aims to determine if higher doses improve tumor control without compromising quality of life.
What are the potential side effects?
Potential side effects include typical radiation therapy risks such as skin irritation at the treatment site, fatigue, urinary issues like increased frequency or discomfort during urination; bowel changes including diarrhea; erectile dysfunction; and possibly more serious complications related to high-dose exposure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am willing and able to agree to the study's procedures.
Select...
My prostate cancer diagnosis was confirmed through a biopsy.
Select...
I am a man over 18 years old.
Select...
I can take care of myself and am up and about more than 50% of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have not had pelvic radiotherapy, chemotherapy, or surgery for prostate cancer.
Select...
I have been cancer-free for at least 3 years, except for non-melanoma skin cancer.
Select...
I am not planning to receive any other cancer treatments while on this trial.
Select...
I do not have inflammatory colitis, active lupus, scleroderma, or any active collagen vascular disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
maximum tolerated dose (MTD)
Secondary study objectives
Adverse events
Health-related quality of life
Overall survival
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Stereotactic Ablative RadiotherapyExperimental Treatment1 Intervention
Stereotactic Ablative Radiotherapy (SABR)

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,081 Previous Clinical Trials
1,056,298 Total Patients Enrolled
16 Trials studying Prostate Cancer
2,100 Patients Enrolled for Prostate Cancer
Raquibul Hannan, MDPrincipal InvestigatorUniversity of Texas Southwestern Medical Center
1 Previous Clinical Trials
25 Total Patients Enrolled

Media Library

Stereotactic Ablative Radiotherapy (SABR) (Radiation) Clinical Trial Eligibility Overview. Trial Name: NCT02353819 — Phase 1
Prostate Cancer Research Study Groups: Stereotactic Ablative Radiotherapy
Prostate Cancer Clinical Trial 2023: Stereotactic Ablative Radiotherapy (SABR) Highlights & Side Effects. Trial Name: NCT02353819 — Phase 1
Stereotactic Ablative Radiotherapy (SABR) (Radiation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02353819 — Phase 1
~21 spots leftby Jan 2030
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top